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Rimegepant for Pediatric Migraine
Study Summary
This trial will test if a new drug, BHV-3000, is safe and effective in treating migraines in children and adolescents.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
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- I am between 6 and 17 years old and will not turn 18 during the study.I have had a stable mental health condition for at least 6 months.I have had or will have surgery with general anesthesia less than 8 weeks before the screening.I have had surgery on my stomach or intestines that affects how my body processes food.I have had migraines for more than 6 months.I've had 1-8 severe attacks a month in the last 2 months, lasting over 3 hours.I can have blood drawn without difficulty.I am not using any CGRP antagonist medications like erenumab.My migraine prevention medication dose has been stable for 12 weeks.You have a history of trying to harm yourself or have a serious mental illness.I stopped taking my preventive migraine medication over 90 days ago.I do not have uncontrolled high blood pressure, diabetes, or life-threatening allergies.I am on one medication that might prevent migraines, but it's not a CGRP antagonist.I have a history of serious head injury or a neurological condition that could affect my brain function.I weigh more than 40 kg.You can explain the difference between a migraine and other kinds of headaches in words.I do not have severe pain that would stop me from joining this study.I have a history of cluster or hemiplegic migraine headaches.I have been on a stable dose of migraine prevention medication for at least 12 weeks.I am on one medication that might prevent migraines, but it's not a CGRP antagonist.I am between 6 and 17 years old and will not turn 18 during the study.You can explain the difference between migraines and other types of headaches using words.I can have blood drawn without difficulty.I stopped taking my preventive migraine medication over 90 days ago.I have or had liver disease or viral hepatitis.
- Group 1: BHV3000 (active drug)
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are the findings of this trial in line with previous research on BHV3000?
"BHV3000 was first studied in 2019 at Neurology Diagnostics Inc. and, as of now, 62 studies have been completed. Right now, there are 7 trials recruiting patients with most of them located in Phoenix, Arizona."
Are there specific medical criteria that patients must meet to join this trial?
"This clinical trial is looking for 1440 participants who are currently suffering from sick headaches. The ideal candidate will be between the ages of 6 and 17, and must also meet the following criteria: Prophylactic migraine medication use is permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study., Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases., Previously discontinued prophylactic migraine medication must have done so"
In how many distinct facilities is this research being conducted?
"The trial is based in Phoenix Children's (Phoenix, Arizona), Chicago Headache Center & Research Institute (Chicago, Illinois), Access Clinical Trials, Inc. (Nashville, Tennessee) as well as 100 other clinics around the country."
What makes this clinical trial unique compared to other similar research projects?
"7 clinical trials involving the active drug BHV3000 are ongoing in 252 cities and 9 countries. The first trial was sponsored by Biohaven Pharmaceuticals, Inc. in 2019. That study reached its Phase 2 approval stage after 60 patients completed the trial. 62 other trials have been conducted since then."
Will this experiment be testing elderly individuals above the age of 60?
"This trial is only open to patients aged 6-17, of which there are 35 other studies. If a patient is outside of this age bracket, they may be eligible for the 118 other trials conducted with senior citizens."
Has BHV3000 (active drug) received FDA approval?
"BHV3000 (active drug) is being trialled in Phase 3, which means that while there is evidence of efficacy, safety has been well-supported through multiple rounds of testing--we've given it a score of 3."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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